Z-6 Atrioseptostomy Catheter
K-Number: K211910 · 2021-07-19
ApplicantNuMED, Inc.
Decision Date2021-07-19
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Z-6 Atrioseptostomy Catheter is a medical device manufactured by NuMED, Inc.. It received FDA 510(k) clearance on 2021-07-19 under approval number K211910. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Z-6 Atrioseptostomy Catheter?
Z-6 Atrioseptostomy Catheter is a medical device that received FDA 510(k) clearance on 2021-07-19. It is manufactured by NuMED, Inc.. The 510(k) number is K211910.
When was Z-6 Atrioseptostomy Catheter approved by the FDA?
Z-6 Atrioseptostomy Catheter received FDA 510(k) clearance on 2021-07-19, under approval number K211910.
What company makes Z-6 Atrioseptostomy Catheter?
Z-6 Atrioseptostomy Catheter is manufactured by NuMED, Inc..
What is the FDA product code for Z-6 Atrioseptostomy Catheter?
The FDA product code for Z-6 Atrioseptostomy Catheter is DXF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.